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510(k) K033105

CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT by Trinity Biotech USA — Product Code MXJ

K033105 is an FDA 510(k) premarket notification submitted by Trinity Biotech USA for the device "CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT". The FDA issued a decision of Substantially Equivalent on July 13, 2004. The device falls under product code MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1), a Class II device regulated under 21 CFR 866.3305. Trinity Biotech USA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2004
Date Received
September 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Trinity Biotech USA

  • K140455 — CAPTIA MEASLES IGM (May 22, 2014)
  • K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (July 13, 2004)
  • K033064 — MYCOPLASMA IGG (November 26, 2003)
  • K033083 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (November 26, 2003)
  • K033079 — CHLAMYDIA IGG ELISA TEST SYSTEM (November 26, 2003)
  • K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM (November 26, 2003)
  • K033067 — PYLORI IGG (November 26, 2003)
  • K033070 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (November 26, 2003)
  • K993839 — ENA PROFILE ELISA TEST SYSTEM (January 12, 2000)
  • K992665 — MACRA LP(A) ENZYME IMMUNOASSAY KIT (November 26, 1999)

Other clearances for product code MXJ

  • K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Control (September 20, 2023)
  • K220923 — Elecsys HSV-1 IgG (08948844160) (October 12, 2022)
  • K181333 — ADVIA Centaur Herpes-1 IgG (August 23, 2018)
  • K162276 — SeraQuest Herpes Type 1 Specific IgG (October 1, 2016)
  • K143236 — Theranos Herpes Simplex Virus-1 IgG Assay (July 2, 2015)
  • K131334 — HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST (February 28, 2014)
  • K120625 — ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV (July 25, 2012)
  • K120959 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT (June 22, 2012)
  • K103363 — ZEUS ELISA HSV GC-I IGG TEST SYSTEM (April 26, 2011)
  • K090409 — BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYS (May 8, 2009)

FDA data resources